Job Description
**Job Summary** Manage External Manufacturing change controls, lead direct reports, and develop relationships with end users to ensure smooth process execution. Within this role, you will be responsible for working within the QA Change Control Team to primarily facilitate activities and relationships regarding External Manufacturing change controls. **Key Responsibilities** * Lead and manage direct reports, working to develop and oversee their performance and growth. * Meet with the External Manufacturing department to discuss changes for applicable products. * Maintain internal databases and track change notifications. * Partner with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Process and associated procedures. * Develop relationships with end users and provide advice on best practices/strategy for changes that require partner notification. * Develop, monitor, and communicate metrics to ensure the health of the partner notification process. * Partner with counterparts to ensure global alignment of processes, systems, and procedures. * Partner with colleagues in other departments on strategies to ensure changes do not impact supply. * Assist as needed in audits and inspections. * Review and approve Change Proposals as required. **Requirements** * Knowledgeable in Biotech/Pharmaceutical Quality systems inclusive of cGMP, FDA regulations, and familiarity with ICH guidelines and global regulatory. * Ability to perform independent work requiring attention to detail, accuracy, scientific judgment, and a consistent record of shifting thought processes quickly from one task to another. * Aptitude to comprehend, analyze, and interpret process and systems information, technical procedures, reports, and regulations to make decisions in a GMP environment. * Proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan. * Excellent interpersonal, written, and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning in order to be responsive. * Trust and build strategic relationships. * Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint; Experience with Quality Management Systems heavily preferred. **Qualifications** * Bachelor's in a scientific or engineering discipline or related field with 8+ years experience in a combination of Quality, Production, Engineering, Regulatory (Chemistry, Manufacturing, and Control) and/or Laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements. Experience in change control function strongly preferred.